OPAXIO(TM) Combined with Alimta(R) Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer
SEATTLE, Aug. 3 /PRNewswire-FirstCall/ — Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced results from a study released by Dartmouth-Hitchcock Medical Center at the International Association for the Study of Lung Cancer (IASLC) 13th World Conference on Lung Cancer. The study demonstrated that in patients with advanced non-small cell lung cancer (NSCLC), the combination of OPAXIO (paclitaxel poliglumex) and Alimta(R) (pemetrexed) was well tolerated and resulted in median progression-free survival of 3.3 months.
The study, led by Dr. J. R. Rigas, enrolled twelve patients, six to each of two dose levels. Patients were treated in 21-day cycles, with cohort one receiving 135 mg/m2 of paclitaxel poliglumex and 500 mg/m2 of pemetrexed, and cohort two receiving 175 mg/m2 of paclitaxel poliglumex and 500 mg/m2 of pemetrexed. None of the patients in cohort one had an initial dose-limiting toxicity (IDLT) with two cycles of therapy. There was one IDLT of infection with neutropenia in cohort two. Aside from grade 3 fatigue in two patients, there were no grade 3 or greater nonhematologic toxicities. A median of 4.5 cycles was delivered in each cohort.
The best response was stable disease in nine patients. Two patients remain without evidence of disease progression, and six patients were alive at time of data presentation. Median progression free survival was 3.3 months.
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OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue’s exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.
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Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
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This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of our securities. Specifically, the risks and uncertainties that could affect the development of OPAXIO include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO in particular, including, without limitation, the potential for OPAXIO to be proved safe and effective (or to achieve response rates) for the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and administrative governmental authorities, the possibility that the FDA will not approve a phase III registration strategy for paclitaxel poliglumex if proposed by CTI, CTI’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling OPAXIO. You should also review the risk factors listed or described from time to time in CTI’s filings with the Securities and Exchange Commission including, without limitation, CTI’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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